Cited by 338Liver Disease Diagnosis and TreatmentLiver Diseases and ImmunityLiver physiology and pathology

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A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

Ratziu, Vlad, de Ledinghen, Victor, Oberti, Fréderic, Mathurin, Philippe, Wartelle-Bladou, Claire, Renou, Christophe, Sogni, Philippe, Maynard, Marianne, Larrey, Dominique, Serfaty, Lawrence, Bonnefont-Rousselot, Dominique, Bastard, Jean-Philippe, Rivière, Marc, Spénard, Jean·2011·Journal of Hepatology

DOI 10.1016/j.jhep.2010.08.030

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Abstract

Background & aims Nonalcoholic steatohepatitis (NASH) is a prevalent liver disease associated with increased morbidity and mortality. Ursodeoxycholic acid (UDCA) may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH.Methods We conducted a 12-month, randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy and safety of HD-UDCA (28-35 mg/kg per day) in 126 patients with biopsy-proven NASH and elevated alanine aminotransferase (ALT) levels. The primary study end point was reduction in ALT levels from baseline in patients treated with HD-UDCA compared with placebo. Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability.Results HD-UDCA significantly reduced mean ALT levels -28.3% from baseline after 12 months compared with -1.6% with placebo (p<0.001). At the end of the trial, ALT levels normalized (≤35 IU/L) in 24.5% of patients treated with HD-UDCA and in 4.8% of patients who received placebo (p=0.003). Both results were not accounted for by changes in weight during the trial. HD-UDCA significantly reduced the FibroTest® serum fibrosis marker (p<0.001) compared with placebo. HD-UDCA also significantly improved markers of glycemic control and insulin resistance. There were no safety issues in this population.Conclusions Treatment with HD-UDCA was safe, improved aminotransferase levels, serum fibrosis markers, and selected metabolic parameters. Studies with histologic end points are warranted.

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Authors: Ratziu, V., de Ledinghen, V., Oberti, F., Mathurin, P., Wartelle-Bladou, C., Renou, C., Sogni, P., Maynard, M., Larrey, D., Serfaty, L., Bonnefont-Rousselot, D., Bastard, J.-P., Rivière, M., & Spénard, J.
Affiliations: Inserm (FR)
Centre Hospitalier Universitaire d'Angers (FR)
Hôpital Claude Huriez (FR)
Hôpital Cochin (FR)
Hospices Civils de Lyon (FR)
Centre Hospitalier Universitaire de Montpellier (FR)
Hôpital Saint-Antoine (FR)
Assistance Publique – Hôpitaux de Paris (FR)
Université de Montréal (CA)
Corresponding author: Ratziu, Vlad
ORCID: Ratziu, Vlad
Mathurin, Philippe
Sogni, Philippe
Maynard, Marianne
Larrey, Dominique
Serfaty, Lawrence
Bastard, Jean-Philippe
Venue: Journal of Hepatology
Publisher: Elsevier BV
Published: 2011-05
Volume: 54
Issue: 5
Pages: 1011-1019
ISSN: 0168-8278 (ISSN-L)
DOI: 10.1016/j.jhep.2010.08.030
OpenAlex: W2078519195
Cited by: 338
References: 58
Citations by year: 2026: 10 · 2025: 20 · 2024: 24 · 2023: 21 · 2022: 18 · 2021: 26 · 2020: 13 · 2019: 25 · 2018: 14 · 2017: 18 · 2016: 18 · 2015: 32 · 2014: 22 · 2013: 33 · 2012: 33
FWCI: 17.68
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Hepatology (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Funders: Axcan Pharma Inc
Topics: Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
Health Sciences › Medicine › Hepatology › Liver physiology and pathology
Keywords: nonalcoholic steatohepatitis, ursodeoxycholic acid, alanine aminotransferase normalization, liver fibrosis, liver inflammation, insulin resistance, glycemic control, FibroTest, bile acid therapy
MeSH terms: Adult, Blood Glucose, Cholagogues and Choleretics, Dose-Response Relationship, Drug, Fatty Liver, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Insulin, Insulin Resistance, Male, Middle Aged, Ursodeoxycholic Acid, Treatment Outcome, Non-alcoholic Fatty Liver Disease

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A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

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